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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Study conducted to recognised testing guidelines with GLP certification.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Route of administration:
oral: gavage
Vehicle:
other: aqueous solution of 0.5% methocel
Duration of treatment / exposure:
28 days
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
100 mg/kg bw/day (nominal)
Dose / conc.:
400 mg/kg bw/day (nominal)
Dose / conc.:
800 mg/kg bw/day (nominal)
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 100 mg/kg bw/day
Male: 5 animals at 400 mg/kg bw/day
Male: 5 animals at 800 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 100 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 800 mg/kg bw/day
Clinical signs:
no effects observed
Description (incidence and severity):
No toxicologically significant clinical signs were seen during the study and at the post-dose observations performed daily.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No statistically significant differences were observed in body weight or food consumption between control and treated groups throughout the study.
Haematological findings:
no effects observed
Description (incidence and severity):
No changes of toxicological significance were detected in haematological and coagulation parameters.
Urinalysis findings:
effects observed, non-treatment-related
Description (incidence and severity):
Urea levels were increased in both sexes from the low, mid and high dose groups when compared with controls. Although these changes achieved statistical significance at all dose-levels tested, they were considered without any toxicological significance because urea levels detected in all individual animals were within the expected range of historical data (mean, standard deviation: 41.1 mg/ml, 10.3 for males and 47.4 mg/ml, 10.3 for females). No toxicological significance was attributed to all other statistically significant changes observed as they were not corralted with the dose-level and were not consistent between sexes
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
Terminal body weight, absolute and relative organ weights were unaffected by treatment and no macroscopic change was seen in the sacrificed animals that could considered to be treatment-related
Neuropathological findings:
no effects observed
Description (incidence and severity):
Neurotoxicity tests and measurements performed at the end of treatment did not show changes attribuitable to treatment
Dose descriptor:
NOAEL
Effect level:
800 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
800 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Critical effects observed:
not specified
Conclusions:
Not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
800 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification